Roche returns EUA to Hetero for tocilizumab production

Roche has decided that it will not pursue any legal dispute with manufacturers such as Hetero over patent rights against the use of tocilizumab, which Roche manufactures under its brand names Actemra/RoActemra. In an emailed statement to Mint, Roche said its decision not to apply the patent was in line with the “extraordinary circumstances that some (low- and middle-income) countries faced during the pandemic, and the demand for Actemra/Roectemra There was an unprecedented jump in the world.

“Following our decision not to claim any patent rights against the use of Actemra/Roectemra for the treatment of Covid-19 in low- and middle-income countries during the current pandemic, the manufacturer who is willing to produce the drug and able, they can do it. Delay in license negotiations or legal uncertainty regarding our (Roche and Chugai) patent rights,” a Roche spokesperson told Mint.

Hetero’s EUA will provide an additional option for patients to manufacture a non-comparable biologic of its drug (a drug that cannot be viewed as an exact copy of Roche’s brand of tocilizumab) and further up to tocilizumab. Will expand reach.

Worldwide shortages of tocilizumab have been a problem during the first and second wave of the COVID-19 pandemic. At a press event earlier this month, Roche chief executive Bill Anderson said the shortage was a global supply chain issue and yet the company has given 60% of its manufacturing capacity to low- and middle-income countries.

According to experts, Roche’s move to not enforce its patent for this drug has opened doors for other manufacturers in India to develop a biosimilar version of Acetemara. Intas, Biocon and Zydus Cadila are some of the Indian drug makers with expertise in manufacturing such biosimilar drugs.

Roche’s decision not to enforce its patent rights coincides with the ongoing negotiations at the World Trade Organization (WTO), where countries such as India and South Africa have to implement certain provisions of trade-related Intellectual Property Rights (TRIPS) for COVID-19. Asking for forgiveness. 19 Treatment, diagnosis and vaccines. More than 100 countries have backed proposals for exemptions amid vaccine inequality and a lack of key drugs to treat COVID-19.

“The patent waiver by Roche would really benefit patients in India and other low and middle-income countries if the price of tocilizumab is cut and Roche shares the technology so that the biosimilar manufacturer WHO pre-qualifies for export in low and medium-income countries. -income countries,” said Lina Menghani, global IP consultant for the MSF Access Campaign, a campaign for access to essential medicines launched by Médecins Sans Frontieres, or Doctors Without Borders.

Menghani said price is still one of the major barriers for patients to access drugs like tocilizumab. In India, the price of a vial of tocilizumab ranges between ₹45,000 more ₹60,000. Activists fear that once a high price point is set by an innovator company, the entry of a biosimilar manufacturer will not lead to a drastic change in pricing.

Hetero did not respond to questions from Mint about the price at which it was planning to sell its biosimilars.

Big pharma has been under pressure to share technology to manufacture vaccines and expand COVID-19 treatments.

In addition to Roche, companies such as Eli Lilly, Merck and Gilead have shared technology for repurchased drugs that have been used to treat moderate to severe COVID-19 patients. US drugmaker Gilead has shared technology for its anti-viral drug remdesivir with 10 generic drugmakers, most of them in India, while Eli Lilly has patented another repurposed drug for Covid-19, baricitinib. have decided to do. Merck has granted voluntary licenses to six Indian generic manufacturers for its antiviral drug Molnupiravir.